Remicade® Crohn's Disease Registry Across Canada (Study P02793)

Terminated

• Conditions: Crohn's Disease
• Interventions: Other: Data collection post infusion

• Registration Number: NCT00755937
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This registry is a multi-center, prospective, observational program that will gather and analyze data on subjects with Crohn's disease being treated with Remicade® as per approved product monograph in Canada. In contrast to a controlled clinical trial, there is no imposed experimental intervention and treatment with Remicade® is determined solely by the subject's physicians. Thus, the data captured and reported in this registry will reflect a "real world" approach to the treatment of Crohn's disease with Remicade®.

Detailed Description

Subjects will be selected for this registry using a non-probability sampling method.

Study Timeline

• Study Start: 2002-02
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Study First Submitted: 2008-08-26
• Study First Submitted QC: 2008-09-17
• Study First Posted: 2008-09-19
• Results First Submitted: 2008-09-29
• Results First Submitted QC: 2009-04-24
• Results First Posted: 2009-06-11
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-06-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 556

Inclusion Criteria

• Patient was given the Patient Information Brochure; AND,
• Patient has never been treated with Remicade® (patient is naïve to Remicade® at the time of registration); AND,
• Patient is a good candidate to receive Remicade® as per the product monograph; AND,
• Patient has agreed to complete the Patient Diary for one week prior to each visit in the registry; AND,
• Patient has signed the approved consent form.

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Exclusion Criteria

• Per product monograph

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects receiving Remicade	Data collection post infusion	Crohn's disease subjects receiving Remicade® per Product Monograph.

Primary Outcome Measures

Name	Time	Method
Clinical Response at 12 Months (Decrease in Crohn's Disease Activity Index [CDAI]>= 70 Points AND >= 25% From Baseline).	12 months after baseline	CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is \< 150, and moderate to severe disease ranges from 220 to 450.
Clinical Response at 24 Months (Decrease in CDAI >= 70 Points AND >= 25% From Baseline).	24 months after baseline	CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is \< 150, and moderate to severe disease ranges from 220 to 450.
Clinical Response at 36 Months (Decrease in CDAI >= 70 Points AND >= 25% From Baseline).	36 months after baseline	CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is \< 150, and moderate to severe disease ranges from 220 to 450.
Clinical Remission at 12 Months (CDAI <= 150 Points).	12 months after baseline	CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is \< 150, and moderate to severe disease ranges from 220 to 450.
Clinical Remission at 24 Months (CDAI <= 150 Points).	24 months after baseline	CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is \< 150, and moderate to severe disease ranges from 220 to 450.
Clinical Remission at 36 Months (CDAI <= 150 Points).	36 months after baseline	CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is \< 150, and moderate to severe disease ranges from 220 to 450.

Secondary Outcome Measures

Name	Time	Method
Number of Serious Adverse Events	Throughout study (up to 36 months)